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Letter to the Editor

College of American Pathologists (CAP) Microbiology Committee Perspective: the Need for Verification Studies

Christina M. Wojewoda, Neil W. Anderson, Romney M. Humphries, Isabella W. Martin, Blaine A. Mathison, Allison R. McMullen, Frederick S. Nolte, David R. Peaper, Dylan R. Pillai, Carol A. Rauch, Dan D. Rhoads, Susan E. Sharp, Rosemary C. She, Patricia J. Simner, Kaede V. Sullivan, Elitza S. Theel, Angela M. Theiss, Richard B. Thomson Jr., Bobbi S. Pritt
Alexander J. McAdam, Editor
Christina M. Wojewoda
aUniversity of Vermont Medical Center, Burlington, Vermont, USA
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Neil W. Anderson
bWashington University School of Medicine, St. Louis, Missouri, USA
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Romney M. Humphries
cAccelerate Diagnostics, Tucson, Arizona, USA
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Isabella W. Martin
dDartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA
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Blaine A. Mathison
eARUP Laboratories, Salt Lake City, Utah, USA
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Allison R. McMullen
fMedical College of Georgia at Augusta University, Augusta, Georgia, USA
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Frederick S. Nolte
gMedical University of South Carolina, Charleston, South Carolina, USA
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David R. Peaper
hYale School of Medicine, New Haven, Connecticut, USA
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Dylan R. Pillai
iAlberta Public Laboratories, Ltd., Calgary, Alberta, Canada
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Carol A. Rauch
jVanderbilt University Medical Center, Nashville, Tennessee, USA
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Dan D. Rhoads
kCase Western Reserve University, Cleveland, Ohio, USA
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Susan E. Sharp
lCopan Diagnostics, Murrieta, California, USA
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Rosemary C. She
mKeck School of Medicine of the University of Southern California, Los Angeles, California, USA
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Patricia J. Simner
nJohns Hopkins, Baltimore, Maryland, USA
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Kaede V. Sullivan
oTemple University Health System, Philadelphia, Pennsylvania, USA
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Elitza S. Theel
pMayo Clinic, Rochester, Minnesota, USA
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Angela M. Theiss
aUniversity of Vermont Medical Center, Burlington, Vermont, USA
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Richard B. Thomson Jr.
qEvanston Hospital, NorthShore University HealthSystem, Evanston, Illinois, USA
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Bobbi S. Pritt
pMayo Clinic, Rochester, Minnesota, USA
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Alexander J. McAdam
Boston Children's Hospital
Roles: Editor
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DOI: 10.1128/JCM.02105-19
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LETTER

On behalf of the Microbiology Committee of the College of American Pathologists (CAP), we respond to the recent commentary by Kirby and colleagues on the topic of bringing in new antimicrobial susceptibility testing (1). The authors state that “there is a lack of clarity regarding verification requirements for bringing in testing for each new antibiotic using platforms and methods that are already established in the clinical laboratory” and argue that quality control can be used in place of conventional verification studies (i.e., verification of accuracy and precision). While we appreciate the intent behind the authors’ arguments, we wish to point out that the State Operations Manual of the Centers for Medicare and Medicaid Services (CMS) (2) clearly defines the requirements for verification of performance specifications for all nonwaived test systems implemented in the laboratory on or after 24 April 2003. According to this document (2), laboratories are required to verify performance specifications for “an analyte added to a test system that can measure multiple analytes which the laboratory has been using for patient testing but has not previously reported patient results for this particular analyte.” According to the standard in §493.1253 of the Electronic Code of Federal Regulations (3), verification studies must include an assessment of accuracy, precision, and reportable ranges for test results. Laboratories must also verify that the reference intervals provided by the manufacturer are appropriate for the patient population that the laboratory serves.

The CAP has deemed status as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) and must act in accordance with federal law. Thus, the CAP and other agencies with deemed status must require laboratories to carry out appropriate verification studies in accordance with CLIA. While all of the components listed above must be included in these studies, the type and extent of studies are at the discretion of the laboratory director. The Clinical and Laboratory Standards Institute (CLSI) provides clear guidance for performing these verification studies and serves as a valuable reference for laboratories wishing to implement new antimicrobial susceptibility testing (4).

ACKNOWLEDGMENTS

This letter was submitted with approval from the College of American Pathologists.

Dr. Romney M. Humphries is employed by Accelerate Diagnostics, Inc., and owns stocks in the company. Dr. Richard B. Thomson serves as a consultant for Accelerate Diagnostics, Inc., and is the Chair of the Microbiology Expert Panel for the CLSI. Dr. Dan D. Rhoads receives research funding for work on novel antibacterial agents through Shionogi Inc., Tetraphase Pharmaceuticals Inc., and Venatorx Pharmaceuticals. The other authors have no relevant conflicts of interest.

FOOTNOTES

  • For the author reply, see https://doi.org/10.1128/JCM.02062-19.

  • Copyright © 2020 American Society for Microbiology.

All Rights Reserved.

REFERENCES

  1. 1.↵
    1. Kirby JE,
    2. Brennan-Krohn T,
    3. Smith KP
    . 2019. Bringing antimicrobial susceptibility testing for new drugs into the clinical laboratory: removing obstacles in our fight against multidrug-resistant pathogens. J Clin Microbiol 57:e01270-19. doi:10.1128/JCM.01270-19.
    OpenUrlAbstract/FREE Full Text
  2. 2.↵
    Centers for Medicare and Medicaid Services. 2017. State operations manual, Appendix C. Survey procedures and interpretive guidelines for laboratories and laboratory services, §493.1253. Centers for Medicare and Medicaid Services, Washington, DC. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_c_lab.pdf. Accessed 11 December 2019.
  3. 3.↵
    Centers for Medicare and Medicaid Services. 2003. Standard: establishment and verification of performance specifications, §493.1253. In Electronic Code of Federal Regulations. 42CFR493.1253. https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5#se42.5.493_11253. Accessed 12 December 2019.
  4. 4.↵
    Clinical Laboratory Standards Institute (CLSI). 2015. Verification of commercial microbial identification and antimicrobial susceptibility testing systems, 1st ed. CLSI guideline M52. Clinical and Laboratory Standards Institute, Wayne, PA.
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College of American Pathologists (CAP) Microbiology Committee Perspective: the Need for Verification Studies
Christina M. Wojewoda, Neil W. Anderson, Romney M. Humphries, Isabella W. Martin, Blaine A. Mathison, Allison R. McMullen, Frederick S. Nolte, David R. Peaper, Dylan R. Pillai, Carol A. Rauch, Dan D. Rhoads, Susan E. Sharp, Rosemary C. She, Patricia J. Simner, Kaede V. Sullivan, Elitza S. Theel, Angela M. Theiss, Richard B. Thomson Jr., Bobbi S. Pritt
Journal of Clinical Microbiology Mar 2020, 58 (4) e02105-19; DOI: 10.1128/JCM.02105-19

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College of American Pathologists (CAP) Microbiology Committee Perspective: the Need for Verification Studies
Christina M. Wojewoda, Neil W. Anderson, Romney M. Humphries, Isabella W. Martin, Blaine A. Mathison, Allison R. McMullen, Frederick S. Nolte, David R. Peaper, Dylan R. Pillai, Carol A. Rauch, Dan D. Rhoads, Susan E. Sharp, Rosemary C. She, Patricia J. Simner, Kaede V. Sullivan, Elitza S. Theel, Angela M. Theiss, Richard B. Thomson Jr., Bobbi S. Pritt
Journal of Clinical Microbiology Mar 2020, 58 (4) e02105-19; DOI: 10.1128/JCM.02105-19
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KEYWORDS

antimicrobial agents
susceptibility testing

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